| Comparative safety of amphotericin B lipid complex and amphotericin B deoxycholate as aerosolized antifungal prophylaxis in lung-transplant recipients. | |
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MedLine Citation:
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PMID: 14742987 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Aerosolized administrations of amphotericin B deoxycholate (AmBd) and amphotericin B lipid complex (ABLC) in lung transplant recipients were compared for safety and tolerability. The incidence of invasive fungal infections in patients receiving aerosolized amphotericin B formulations as sole prophylaxis was determined. METHODS: A prospective, randomized (1:1), double-blinded trial was conducted with 100 subjects. AmBd and ABLC were administered postoperatively by nebulizer at doses of 25 mg and 50 mg, respectively, which were doubled in mechanically ventilated patients. The planned treatment was once every day for 4 days, then once per week for 7 weeks. Treatment-related adverse events and invasive fungal infections were quantitated for 2 months after study drug initiation. RESULTS: Intent-to-treat analysis revealed study drug was discontinued for intolerance in 6 of 49 (12.2%) and 3 of 51 (5.9%) patients in the AmBd- and ABLC-treated groups, respectively (p=0.313). Subjects receiving AmBd were more likely to have experienced an adverse event (odds ratio 2.16, 95% confidence interval 1.10, 4.24, p=0.02). Primary prophylaxis failure within 2 months of study drug initiation was observed in 7 of 49 (14.3%) AmBd-treated patients and 6 of 51 (11.8%) ABLC-treated patients. No fungal pneumonias were observed. Only two (2%) patients experienced documented primary prophylaxis failure with Aspergillus infections within the follow-up period. CONCLUSIONS: Both aerosol AmBd and ABLC appear to be associated with a low rate of invasive pulmonary fungal infection in the early posttransplant period. Patients receiving ABLC were less likely to experience a treatment-related adverse event. |
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Authors:
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Richard H Drew; Elizabeth Dodds Ashley; Daniel K Benjamin; R Duane Davis; Scott M Palmer; John R Perfect |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S. |
Journal Detail:
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Title: Transplantation Volume: 77 ISSN: 0041-1337 ISO Abbreviation: Transplantation Publication Date: 2004 Jan |
Date Detail:
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Created Date: 2004-01-26 Completed Date: 2004-02-27 Revised Date: 2009-11-03 |
Medline Journal Info:
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Nlm Unique ID: 0132144 Medline TA: Transplantation Country: United States |
Other Details:
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Languages: eng Pagination: 232-7 Citation Subset: IM |
Affiliation:
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Division of Infectious Diseases, Duke University Medical Center, Durham, NC 27710, USA. richard.drew@duke.edu |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Aerosols Aged Amphotericin B / administration & dosage, adverse effects, therapeutic use* Continental Population Groups Deoxycholic Acid / administration & dosage, adverse effects, therapeutic use* Double-Blind Method Drug Combinations Female Heart-Lung Transplantation / physiology Humans Lung Diseases / classification, surgery Lung Transplantation / physiology* Male Middle Aged Mycoses / prevention & control* Phosphatidylcholines / administration & dosage, adverse effects, therapeutic use* Phosphatidylglycerols / administration & dosage, adverse effects, therapeutic use* Postoperative Complications / prevention & control* Retrospective Studies |
| Grant Support | |
ID/Acronym/Agency:
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R03HD42940-01/HD/NICHD NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Aerosols; 0/Drug Combinations; 0/Phosphatidylcholines; 0/Phosphatidylglycerols; 0/liposomal amphotericin B; 1397-89-3/Amphotericin B; 83-44-3/Deoxycholic Acid; 87687-70-5/amphotericin B, deoxycholate drug combination |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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